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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS PRISMATIC LAMP, SURGICAL

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MAQUET SAS PRISMATIC LAMP, SURGICAL Back to Search Results
Catalog Number ARD567027999
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/15/2022
Event Type  malfunction  
Event Description
On (b)(6) 2022 getinge became aware of an issue with one of our surgical lights - prismatic. As it was stated, the label of the device was missing. No injury was reported due to mentioned issue, however, we decided to report this case in abundance of caution as label falling off into sterile field or during procedure may cause contamination.
 
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation. Device not returned to manufacturer.
 
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Brand NamePRISMATIC
Type of DeviceLAMP, SURGICAL
Manufacturer (Section G)
MAQUET SAS
parc de limere
avenue de la pomme de pin
ardon
Manufacturer Contact
pascal jay
parc de limere
avenue de la pomme de pin
ardon 
MDR Report Key13786627
MDR Text Key287587233
Report Number9710055-2022-00076
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/16/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/16/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberARD567027999
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received03/21/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/13/1997
Is the Device Single Use? No
Type of Device Usage Reuse

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